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Job description
Overview:
Position Overview
We are seeking a highly qualified Senior Systematic Evidence Review Scientist / Principal Investigator (PI) to lead scientific and technical activities supporting the Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau (MCHB), Newborn Screening (NBS) program, and Recommended Uniform Screening Panel (RUSP) evidence review initiative.
The PI will provide scientific leadership for the design, execution, management, and dissemination of systematic clinical evidence reviews, scoping reviews, evidence scans, economic analyses, and population-level assessments addressing conditions considered for newborn screening.
The successful candidate will lead multidisciplinary scientific teams, engage clinical and technical subject matter experts, oversee evidence synthesis and quality assessment, and ensure that all technical deliverables meet Federal requirements for scientific rigor, accessibility, quality, and timeliness.
Primary Responsibilities
1. Scientific Leadership and Evidence Review
Serve as the senior scientific lead and primary technical authority for systematic evidence review activities.
Direct evidence reviews of rare, genetic, metabolic, and other medical conditions considered for newborn screening and potential inclusion on the RUSP.
Develop and refine evidence review frameworks, research questions, protocols, and analytic methodologies.
Apply rigorous systematic review methodologies appropriate for conditions where randomized controlled trials may be limited or unavailable.
Evaluate evidence from observational studies, diagnostic accuracy studies, natural history studies, registries, clinical studies, screening programs, and gray literature.
Oversee literature searches across biomedical, genetics, clinical, and public health databases.
Ensure appropriate study screening, selection, data extraction, risk-of-bias assessment, evidence grading, and evidence synthesis.
Evaluate the benefits, harms, clinical outcomes, implementation considerations, and population-level implications of newborn screening.
Ensure scientific conclusions are transparent, reproducible, and supported by the available evidence.
2. Newborn Screening and RUSP Support
Apply knowledge of newborn screening policy, clinical practice, public health systems, and evidence-based screening principles.
Evaluate screening tests, confirmatory testing, treatment pathways, and clinical outcomes.
Assess screening characteristics including sensitivity, specificity, predictive values, false-positive and false-negative rates, and relevant cutoff considerations.
Assess the readiness and feasibility of implementing screening through state public health newborn screening programs.
Evaluate health-system, family, psychosocial, ethical, and population-level impacts.
Contribute to frameworks and Manuals of Procedures (MOPs) used to evaluate candidate conditions for newborn screening.
3. Technical Expert Panel and SME Management
Recruit, coordinate, and manage multidisciplinary clinical and scientific subject matter experts.
Develop recommendations for Technical Expert Panel and Clinical Evidence Review Group membership.
Ensure appropriate conflict-of-interest screening and confidentiality/NDA requirements for participating experts.
Facilitate expert meetings and obtain objective scientific input throughout the evidence review process.
Integrate expert input while maintaining methodological independence and scientific objectivity.
4. Task Order 1 Leadership
Provide scientific leadership for Task Order 1 activities, including:
Clinical evidence review of biliary atresia and approaches for newborn screening.
Development of a framework/manual for determining readiness of conditions for state newborn screening.
Evidence scans for approximately 10-15 candidate conditions.
Simultaneous systematic evidence reviews for candidate conditions.
Economic analyses of candidate conditions.
Development of technical and consumer-friendly reports.
Support for NBS Stakeholder Workgroup activities.
Technical meetings, presentations, briefings, and other activities requested by the HRSA COR.
5. Project and Team Management
Lead multidisciplinary teams consisting of epidemiologists, systematic reviewers, clinicians, geneticists, biostatisticians, health economists, public health experts, information specialists, technical writers, and other specialists.
Establish clear scientific roles, responsibilities, timelines, and deliverable milestones.
Coordinate multiple evidence reviews operating concurrently.
Monitor progress against approved schedules and identify potential schedule, resource, methodological, or quality risks.
Maintain effective communication with HRSA/MCHB staff, the COR, SMEs, subcontractors, and academic partners.
Support development and maintenance of project management tracking systems.
6. Scientific Writing and Reporting
Direct preparation of draft and final evidence review reports.
Review and approve technical analyses, tables, figures, evidence profiles, and recommendations.
Translate complex scientific findings into clear, concise reports suitable for Federal decision makers and public health stakeholders.
Oversee development of consumer-facing summaries written for an approximately 8th-grade reading level.
Support preparation of manuscripts for peer-reviewed publication.
Review and respond to scientific and editorial comments and coordinate revisions.
7. Quality Assurance and Compliance
Establish and enforce scientific quality-control procedures throughout the evidence review lifecycle.
Ensure deliverables comply with applicable HRSA/MCHB requirements, contract requirements, and approved methodologies.
Ensure appropriate documentation of literature searches, screening decisions, data extraction, analytic methods, and evidence assessments.
Oversee internal technical review and editorial review prior to submission.
Ensure electronic deliverables are developed in accordance with applicable HHS Section 508 accessibility requirements .
Support quality-control processes for readability and public-facing materials.
Ensure all personnel and SMEs comply with applicable confidentiality, conflict-of-interest, records-management, and Federal requirements.
Required Qualifications
Advanced degree in a relevant discipline such as: Medicine (MD/DO)
Epidemiology
Public Health
Health Services Research
Clinical Research
Genetics/Genomics
Biostatistics
Health Policy
Nursing or allied clinical sciences
Related biomedical or population health discipline.
Demonstrated senior-level experience conducting or directing systematic clinical evidence reviews .
Demonstrated experience with rare diseases, genetic conditions, clinical evidence assessment, newborn screening, or closely related public health/clinical research.
Experience developing systematic review protocols and research questions.
Experience evaluating study quality and risk of bias using validated methodologies.
Experience synthesizing clinical evidence from heterogeneous study designs.
Experience leading multidisciplinary scientific teams.
Strong scientific writing, technical communication, and presentation skills.
Demonstrated ability to manage complex, multi-workstream Federal or public health projects.
Experience working with clinical and scientific subject matter experts.
Ability to translate scientific evidence into population-level public health and policy recommendations.
Preferred Qualifications
Direct experience with the HRSA/MCHB newborn screening program or RUSP process .
Experience evaluating candidate conditions for population-based newborn screening.
Experience with rare genetic, metabolic, or pediatric conditions.
Experience with diagnostic accuracy evidence.
Experience with natural history studies and disease registries.
Experience with newborn screening technologies such as tandem mass spectrometry and genomic sequencing.
Experience conducting health-economic or cost-effectiveness analyses.
Experience with Federal public health agencies, including HHS, HRSA, CDC, NIH, or comparable organizations.
Experience preparing evidence reports for government policy or clinical guideline decisions.
Peer-reviewed publications involving systematic reviews, evidence synthesis, newborn screening, genetics, pediatrics, or public health.
Core Competencies
Systematic evidence review methodology
Evidence synthesis and grading
Clinical epidemiology
Rare disease/genetic disease research
Newborn screening
Public health policy
Diagnostic accuracy assessment
Risk-of-bias assessment
Literature searching and evidence retrieval
Data extraction and analysis
Health economics
Scientific writing
Technical leadership
Expert-panel management
Federal contract/project management
Quality assurance
Section 508-compliant technical communication
Key Performance Expectations
The PI will be expected to:
Provide scientifically rigorous and reproducible evidence reviews.
Successfully manage multiple concurrent evidence-review activities.
Deliver high-quality technical reports within required schedules.
Maintain strong scientific independence and objectivity.
Effectively integrate clinical and technical expert input.
Translate evidence into actionable information for newborn screening policy and public health decision making.
Maintain rigorous quality-control and documentation procedures.
Ensure deliverables meet HRSA/MCHB technical, accessibility, editorial, and contractual requirements.
Serve as a credible senior scientific representative to HRSA/MCHB and associated expert stakeholders.
Reporting Structure
Reports to: Program/Contract Executive or Corporate Project Director
Direct/Functional Leadership: Systematic Review Scientists, Epidemiologists, Biostatisticians, Clinical/Genetic SMEs, Health Economists, Information Specialists, Technical Writers, Quality Assurance Specialists, and supporting project staff.
Primary Government Interface: HRSA/MCHB Contracting Officer's Representative (COR)
Position Type
Senior Key Personnel / Principal Investigator
Work Environment
Primarily remote/contractor facility-based, with occasional travel within the continental United States for technical expert panel meetings, stakeholder meetings, presentations, or other activities approved by HRSA/MCHB.
Proposal Relevance
This position directly supports the solicitation's requirements for Technical Approach, Key Personnel and Academic Credentials, Management Plan and Quality Control , including the need for personnel capable of directing complex public health services, structuring scientific methodologies, conducting systematic clinical evidence reviews, producing population-level policy recommendations, and coordinating academic and medical expert networks.
Skills:
Systematic Evidence Reviews,Newborn Screening (NBS),Rare Genetic & Medical Conditions,Evidence-Based Medicine,Systematic Literature Searches,Clinical Evidence Synthesis,Risk of Bias Assessment,Evidence Grading,RUSP Evaluation & Readiness Assessment,Public Health Policy & Recommendations,Epidemiology & Clinical Research,Observational & Natural History Studies,Health Technology Assessment,Economic & Cost-Effectiveness Analysis,Stakeholder & Technical Expert Panel Management,Scientific Report Writing,Project & Program Management,Quality Assurance / Quality Control,Section 508 Compliance,Medical/Scientific Editing and Publication
Worksite address
rockville, MD, 20849, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.